EU Declaration of Conformity: What Annex IV Requires and Where It Fails

The EU declaration of conformity is the document by which a manufacturer states, on its own responsibility, that the requirements of the regulation have been met. It is the shortest document in a technical file and the one most frequently read by other people.

Who draws up the EU declaration of conformity

Only the manufacturer. Article 19 of Regulation (EU) 2017/745 places the obligation on the manufacturer alone, and no authorised representative, importer, distributor or consultant may sign it on the manufacturer's behalf.

What an authorised representative does is different in kind. Under Article 11(3)(a) it verifies that the EU declaration of conformity has been drawn up. Verifying a document and drafting it are separate acts, and a provider offering to write your declaration is describing something Article 11(4) does not permit.

By drawing up the declaration, the manufacturer assumes responsibility for compliance with the regulation and with all other Union legislation applicable to the device.

What the EU declaration of conformity must contain

Annex IV sets out the minimum content. The declaration contains the name, registered trade name or registered trade mark of the manufacturer and, if applicable, its authorised representative, together with the registered place of business and the address at which they can be contacted.

It contains the Basic UDI-DI. It contains a statement that the declaration is issued under the sole responsibility of the manufacturer. It contains the product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device, including a picture where appropriate.

It contains the risk class of the device in accordance with the classification rules. It contains a statement that the device is in conformity with the regulation and, if applicable, with any other relevant Union legislation providing for the issuing of a declaration of conformity.

It contains references to any common specifications used and to which conformity is declared, and references to the harmonised standards used. Where a notified body has been involved, it contains that body's name and identification number, a description of the conformity assessment procedure performed and identification of the certificate issued.

Finally it contains additional information where applicable, the place and date of issue, the name and function of the person who signed it, and an indication for and on behalf of whom that person signed, together with the signature.

Errors that make an EU declaration of conformity fail verification

Four patterns recur, and none of them are difficult to avoid.

A directive-era declaration presented under the regulation. Company templates persist long after the legal basis has changed, and a document citing a repealed directive does not become compliant by being recent.

A Basic UDI-DI that does not match the record in EUDAMED. Where a device group has been re-grouped after the declaration was issued, the declaration and the database diverge — and both are visible to whoever is checking.

A notified body cited where none was involved. A Class I device that is not supplied sterile, has no measuring function and is not a reusable surgical instrument requires no notified body, and naming one is a claim the manufacturer cannot support.

A missing signatory function. The name is present, the signature is present, the function is not — and the document is incomplete on its face.

Where your EU declaration of conformity is read

Your authorised representative verifies it under Article 11(3)(a) before accepting the mandate. Importers verify it under their own obligations before placing the device on the Union market. Distributors check that it exists before making the device available.

It is required for registration in Türkiye's ÜTS regardless of device class — the single document common to a Class I dressing and a Class III implant. Competent authorities request it first when they request anything.

A declaration that does not survive that scrutiny stops a market entry everything else was ready for. It is worth the hour it takes to check line by line against Annex IV before it is issued.

Four errors that make an EU declaration of conformity fail verification

Sources

Regulation (EU) 2017/745, Article 19 and Annex IV — EU declaration of conformity

Regulation (EU) 2017/746, Article 17 and Annex IV

Regulation (EU) 2017/745, Article 11(3)(a) and Article 11(4)

Tıbbi Cihaz Yönetmeliği, Resmî Gazete 2 June 2021, No 31499 (repeated issue)

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We draw up declarations of conformity for our own devices and verify them for the manufacturers we represent. We are not a law firm and do not provide legal advice.